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LIMITED OFFICIAL USE - PROPRIETARY INFORMATION Audit of the Drug Enforcement Administration’s Prescription Drug Take Back Activities * * * AUDIT DIVISION 20-114 SEPTEMBER 2020 Executive S ummary Audit of the Drug Enforcement Administration’s Prescription Drug Take Back Activities Objective Audit Results The Drug Enforcement Administration (DEA) sponsors Since the inception of Take Back Day in 2010, the DEA bi-annual drug Take Back Days to provide the public has facilitated 18 Take Back Day events at a cost of with a safe, convenient, and anonymous means for almost $74 million. With the help of thousands of law disposing of unused prescription drugs. The objective enforcement agencies across the country, the DEA of this audit was to evaluate the DEA’s policies, reports that it has collected over 12 million pounds of procedures, and practices for the collection, custody, pharmaceuticals. In doing so, the DEA has provided a and disposal of prescription drugs. useful public service, but this audit revealed areas for improvement and ways to enhance the value of the Results in Brief program. The DEA reports that, since 2010, it has facilitated the collection and destruction of over 12 million pounds of DEA Take Back Day Operations – When the DEA unwanted and potentially dangerous pharmaceuticals established the Take Back Day program, it was part of a through its Take Back Day activities. Additionally, law multi-pronged federal approach to combat drug abuse enforcement agency participation in Take Back Day in the United States. As part of that strategy, the DEA events has increased approximately 64 percent over the sought to supplement ongoing community prescription same period. However, we found that the DEA could drug collection efforts by establishing biannual Take advance its Take Back Day events by conducting Back Day events and assisting law enforcement agency regular analysis of Take Back Day activities and results. partners that host these events. We identified Through such analysis, the DEA can better target its additional steps that the DEA can take to improve the efforts to increase law enforcement agency participation reach of the program. For example, the DEA should and community awareness. The DEA should also enact analyze its historical Take Back Day results and other measures to improve law enforcement agency incorporate Take Back Day events into other community participation, particularly in areas with coverage gaps, outreach efforts. In addition, the DEA could use data to ensure that resources are devoted to areas with the that provides information on where prescription drug most need. diversion and opioid use present the greatest challenge to identify locations that would most benefit from Although we did not find evidence that collected drugs expanded efforts to encourage growth in those areas, were lost, stolen, or misused during our testing, we which is an important step toward achieving the found deficiencies in the DEA’s practices in accounting program’s goals. for collected drugs that significantly increased the risk of such problems. For example, the DEA did not have DEA Administration of Take Back Day Activities – adequate supporting documentation for nearly 70 Take Back Day events serve an important purpose. percent of its reported collections or nearly 37 percent However, we found that the DEA’s management and of its reported destructions for its April 2019 Take Back oversight of Take Back Day activities requires prompt Day event. This occurred largely because the DEA did corrective actions to ensure the safeguarding of and not have procedures sufficient to ensure accurate accounting for the collections and their disposal. In reporting. addition, the DEA should take actions to ensure that participating law enforcement agencies are following Recommendations DEA guidance for Take Back Day events. Without such Our report contains 10 recommendations to assist the controls, the DEA cannot be certain that Take Back Day DEA in improving its management and oversight of events are conducted as intended, and that collections Take Back Day collection, custody, and disposal of are correctly reported and properly protected until prescription drugs. destruction. i AUDIT OF THE DRUG ENFORCEMENT ADMINISTRATION’S PRESCRIPTION DRUG TAKE BACK ACTIVITIES TABLE OF CONTENTS INTRODUCTION .......................................................................................... 1 Background ....................................................................................... 1 DEA and National Prescription Drugs Take Back Day ........................ 2 OIG Audit Approach ............................................................................ 3 AUDIT RESULTS .......................................................................................... 5 DEA Take Back Day Operations ............................................................. 5 Expanding Participation and Eliminating Coverage Gaps ................... 5 Encouraging Law Enforcement Participation ................................... 6 Permanent Prescription Drugs Disposal Options .............................. 8 Public Outreach ......................................................................... 9 DEA Administration of Take Back Day Activities ....................................... 9 Support for April 2019 Take Back Day Collections and Destruction ... 10 Timeliness of April 2019 Take Back Day Collections Destruction ...... 14 Take Back Day Performance Metrics Analysis ............................... 15 DEA Policy and Procedures for Take Back Day Activities ................. 17 Guidance to Law Enforcement Agency Partners ............................. 19 CONCLUSION AND RECOMMENDATIONS ....................................................... 21 APPENDIX 1: OBJECTIVE, SCOPE, AND METHODOLOGY .................................. 23 APPENDIX 2: THE DRUG ENFORCEMENT ADMINISTRATION’S RESPONSE TO THE DRAFT AUDIT REPORT ..................................................... 25 APPENDIX 3: OFFICE OF THE INSPECTOR GENERAL ANALYSIS AND SUMMARY OF ACTIONS NECESSARY TO CLOSE THE REPORT ....................... 29 AUDIT OF THE DRUG ENFORCEMENT ADMINISTRATION’S PRESCRIPTION DRUG TAKE BACK ACTIVITIES INTRODUCTION The DEA is responsible for organizing and facilitating prescription drug Take Back Day events nationwide. The DEA has reported that, since the inception of Take Back Day in 2010, over 12 million pounds of pharmaceuticals, including prescription drugs, non-prescription drugs, supplements, and other medications have been collected and disposed of through its sponsored Take Back Day events. In addition, the amount of collections has increased, from about 250,000 pounds during the first Take Back Day event in 2010 to an average of 916,000 pounds per event during 2017 through 2019, as shown in Figure 1 below. Through this program, the DEA is able to provide communities nationwide with an alternative to keeping expired and unused medications in their homes. Figure 1 Take Back Day Collection Totals September 2010 to October 2019 1,000,000 900,000 800,000 700,000 600,000 500,000 400,000 300,000 200,000 100,000 Weight Collections in Lbs 0 Take Back Day Events Source: OIG Analysis Background Several factors, including a growing concern over the effects that prescription drug and other toxic substance disposal is having on public health, led the DEA to establish and pursue national Take Back Days. Another contributing factor was the 2010 Office of National Drug Control Policy’s National Drug Control Strategy (2010 Strategy), which discussed a multi-pronged approach to combatting drug abuse in the United States that involved communities, education, healthcare services, and law enforcement. One important element of the 2010 Strategy was encouraging community prescription drug take-back initiatives. Although many state and local law enforcement agencies were already conducting their own collections, the 2010 Strategy further motivated the DEA’s efforts to establish Take Back Days nationwide. 1 Additionally, the passage of the Secure and Responsible Drug Disposal Act of 2010 (Act) enabled manufacturers, distributors, reverse distributors, retail pharmacies, hospitals and clinics with an on-site pharmacy, and narcotic treatment programs to become authorized collectors. The Act also permitted long-term care facilities to transfer unused and unwanted pharmaceutical controlled substances on behalf of residents and former residents of the facilities for disposal, and allowed prescription drug mail-back programs for consumers to return their unwanted prescription drugs to authorized entities.1 Through the Act, the DEA was empowered to set guidance for these entities to develop a variety of methods of collection and disposal. DEA and National Prescription Drugs Take Back Day The DEA began facilitating Take Back Day events in September 2010 with the goal of providing a safe, convenient, and anonymous means for disposing of prescription drugs. Since that time, Take Back Day events have generally been held twice a year throughout the country.2 The DEA has spent almost $74 million on the program since 2010, excluding personnel costs for staff in the Diversion Control Division’s (DCD) Liaison Section. This amount includes DEA field personnel costs, advertising expenses, Take Back Day supplies for law enforcement partners, collection destruction costs, and Take Back Day-related travel expenses for DEA personnel. Within the DEA, Take Back Day activities are managed by the DCD’s Liaison Section,

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